The US Food and Drug Administration (FDA) has declined to approve Achieve Life Sciences’ drug to treat nicotine dependence in adults, citing unresolved issues found at a third-party manufacturing facility and final product labeling that was not completed by the agency’s action date.
The FDA did not identify any deficiencies related to the drug’s clinical efficacy or safety in its complete response letter, Achieve added in its statement on Monday.
The rejection delays Achieve’s bid to introduce another non-nicotine prescription option for adults trying to quit smoking, with FDA-approved choices still largely limited to Pfizer’s Chantix and GSK’s Zyban, apart from nicotine replacement products.
The experimental drug, called cytisinicline, is a plant-derived compound aimed at helping adults quit smoking by targeting nicotine receptors in the brain to reduce nicotine cravings and withdrawal symptoms, including irritability and sleep problems. Unlike nicotine replacement products such as patches, gums and lozenges, it does not deliver nicotine.
